Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

Not Applicable

Completed

• Conditions: Disorder of Bile Duct Stent; Periampullary Cancer; Complications of Surgical Procedures or Medical Care
• Interventions: Device: Fully covered metal stents; Device: Plastic stents

• Registration Number: NCT01789502
• Lead Sponsor: Inje University

Brief Summary

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Detailed Description

Pancreaticoduodenectomy is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen.

This prospective study is designed to compare the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-02
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Older than 20 years old of age
• Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
• No evidence of distant metastases or locally advanced tumor

Exclusion Criteria

• Unresectable stage of cancer
• Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
• Severe gastric outlet obstruction or duodenal obstruction
• Severe comorbidity (Karnofsky<50%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fully covered metal stents	Fully covered metal stents	Fully covered metal stents are inserted by ERCP
Plastic stents	Plastic stents	Plastic stents are inserted by ERCP

Primary Outcome Measures

Name	Time	Method
Adverse events related to the stent insertion	up to 4weeks	Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.

Secondary Outcome Measures

Name	Time	Method
Re-intervention rate	up to 4weeks	Re-intervention is defined as endoscopic retrograde cholangiopancreatography or percutaneous transhepatic biliary drainage procedures which are required to achieve adequate preoperative biliary drainage after stent insertion.
Hospital stay	up to 1months	Hospital stay is defined as the period between the date of stent insertion and that of discharge.
Surgical outcomes	up to 1months	Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.

Trial Locations

Locations (3)

Daejun Eulji University Hospital; 🇰🇷 Daejun, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Koyang, Gyeonggi-do, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of